510(k) · Cleared
ClearedL10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · OWN Confocal Optical Imaging
Cleared on Nov 19, 2019 as substantially equivalent to K150956 (Novadaq Technologies, Inc., 2016) and 7 other predicates after an 88-day review. Its family tree reaches back 19 generations to 1994. 1 later device descends from it.
- Decided
- Nov 19, 2019
- Review
- 88 days
- Class
- Class II
- Product code
- OWN
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 19 generations to K930667 (1994). 93 ancestors in all, the oldest K811390 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 15 generations between
- 3 generations backK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
- 2 generations backK182160 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688…Stryker · 2018 · Recalled
- 1 generation backK191046 L10 LED Light Source with AIM, L11 LED Light Source with AIMStryker · 2019
- This deviceK192292 L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM…Stryker · 2019
- Descendant · cites it directly · 0 of its ownK243591 OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC · 2025
Show all 19 generations
- Root · 19 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 18 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 17 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 16 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 15 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 14 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 13 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 12 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 11 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 10 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 9 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 8 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- 7 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- 6 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- 5 generations backK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
- 4 generations backK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
- 3 generations backK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
- 2 generations backK182160 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688…Stryker · 2018 · Recalled
- 1 generation backK191046 L10 LED Light Source with AIM, L11 LED Light Source with AIMStryker · 2019
- This deviceK192292 L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM…Stryker · 2019
Most influential descendants
Showing 1 of 1 · See all- K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −18 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −17 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −16 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −15 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −14 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −13 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −12 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −11 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −10 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −9 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −8 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| −7 | K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | Intuitive Surgical, Inc. | 2012 | 2 |
| −6 | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | Intuitive Surgical, Inc. | 2014 | 80 |
| −5 | K141077 | DA Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2014 | 2 |
| −4 | K150956 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | 1 |
| −3 | K161792 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | — |
| −2 | K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K… | Stryker | 2018 | 1 |
| −1 | K191046 | L10 LED Light Source with AIM, L11 LED Light Source with AIM | Stryker | 2019 | — |
| 0 (this device) | K192292 | L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight… | Stryker | 2019 | — |
| +1 | K243591 | OPTOVISION Endoscopic Light Source Unit | Optosurgical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 9 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OWN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OWN device
- #1 K231854 1788 4K Camera System with Advanced Imaging…score 24.9 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150956 | PINPOINT Endoscopic Fluorescence Imaging SystemSummary page 4…pport real-time endoscopic visible imaging. Predicate Device(s): PINPOINT Endoscopic Fluorescence Imaging System (primary K150956, K161792, predicate) K182606 L10 LED L… | 2016 |
| * | K161792 | PINPOINT Endoscopic Fluorescence Imaging SystemSummary page 4…l-time endoscopic visible imaging. Predicate Device(s): PINPOINT Endoscopic Fluorescence Imaging System (primary K150956, K161792, predicate) K182606 L10 LED Light Sour… | 2016 |
| * | K182606 | PINPOINT Endoscopic Fluorescence Imaging SystemSummary page 4…primary K150956, K161792, predicate) K182606 L10 LED Light Source and SafeLight Cable (secondary predicate) K142310, K151243,… | 2018 |
| * | K142310 | Stryker Infrared Fluorescence (IRF) Imaging SystemSummary page 4…K182606 L10 LED Light Source and SafeLight Cable (secondary predicate) K142310, K151243, K173866, K191046… | 2014 |
| * | K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Summary page 4…K182606 L10 LED Light Source and SafeLight Cable (secondary predicate) K142310, K151243, K173866, K191046 L11 LED L… | 2015 |
| * | K173866 | Stryker AIM Light Source and SafeLight cableSummary page 4…ry predicate) K142310, K151243, K173866, K191046 L11 LED Light Source and SafeLight Cable (secondary predicate) K182160, K191046 N… | 2018 |
| * | K191046 | L10 LED Light Source with AIM, L11 LED Light Source with AIMSummary page 4…ate) K142310, K151243, K173866, K191046 L11 LED Light Source and SafeLight Cable (secondary predicate) K182160, K191046 NOTE: The… | 2019 |
| * | K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Summary page 4…K173866, K191046 L11 LED Light Source and SafeLight Cable (secondary predicate) K182160, K191046 NOTE: The predicate devices have not been subject to a design-related recall.… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243591 | OPTOVISION Endoscopic Light Source Unit | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 28 of the 93 ancestors have a recall of any class.
- Of its descendants, K243591 (Optosurgical, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K150956.
How does its category compare?
All OWN devicesOWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OWN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWN
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWN
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWN
197in 2025
MAUDE reports naming product code OWN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 3 | 87 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 208 | 0 | 0 |
| 2015 | 5 | 163 | 0 | 1 |
| 2016 | 2 | — | 0 | 4 |
| 2017 | 5 | 87 | 0 | 12 |
| 2018 | 1 | — | 0 | 11 |
| 2019 | 7 | 81 | 0 | 59 |
| 2020 | 7 | 81 | 0 | 105 |
| 2021 | 4 | 104 | 0 | 312 |
| 2022 | 4 | 41 | 3 | 346 |
| 2023 | 6 | 69 | 0 | 164 |
| 2024 | 1 | — | 1 | 165 |
| 2025 | 3 | 196 | 0 | 197 |
| 2026 | 7 | 63 | 0 | — |
What is it indicated for?
Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLightTM Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue…
Read the full statement (179 words)
Upon intravenous administration of SPY AGENTTM GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLightTM Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the AIM Light Source and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
Upon interstitial administration of SPY AGENT GREEN (ICG drug product), the AIM Light Source and SafeLightTM Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192292: L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192292
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026